BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    Gastrointestinal Boundary Identifier (GIBI HD)

    K Number: K221898 · Decision Jul 28, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    229
    Same Product Code
    648
    Applicant Total
    4
    Review Days
    28

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    Basic Information

    Device Name
    Gastrointestinal Boundary Identifier (GIBI HD)
    K Number
    K221898
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5980
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Reshape Lifesciences
    Date Received
    June 30, 2022
    Decision Date
    July 28, 2022
    Product Code
    KNT
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KNT Tubes, Gastrointestinal (And Accessories)

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    Other Clearances by Reshape Lifesciences

    K Number Device Name
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